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Navigating the Complexities of Newer Technologies When Validating FDA-Regulated Systems
Advancements in technology have forced companies to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and have higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation, and maintaining a system ..
Cost Efficiency and Partnership Models in Contract Manufacturing
The pharmaceutical industry is undergoing a transformative phase, driven by increasing cost pressures, evolving regulatory requirements, and the need for faster time-to-market. In this dynamic environment, contract manufacturing organizations (CMOs) have emerged as critical partners for pharmaceutical companies, offering specialized expertise, scalable production capabilities, and cost-effective solutions. ..
Effective Technical Writing for FDA Submissions
Technical Writing for FDA Submissions is a critical skill for professionals in regulated industries, including pharmaceuticals, medical devices, and biotechnology. Regulatory submissions to the U.S. Food and Drug Administration (FDA) must be clear, precise, and well-structured to ensure compliance and facilitate regulatory review. Poorly written submissions can lead to delays, requests for additional inform..
FDA 483 or Warning Letter? Now what?
The training on “FDA 483 or Warning Letter – Now What?” is designed to empower professionals in FDA-regulated industries with the knowledge and skills necessary to respond effectively to regulatory challenges. FDA 483 observations and Warning Letters signify potential non-compliance issues that require immediate attention to avoid escalated enforcement actions. This webinar provides a comprehensive roadmap ..
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations
In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a raw material or packaging component used in conjunction with the product during the manuf..
A Disinfectant Field Trial that Meets Annex I Guidance
In this informative webinar, we will explore the key elements of a Contamination Control Strategy (CCS) implemented in a recent biopharma disinfectant field trial, following Annex I guidance. The case study highlights the use of a ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide to control bioburden in a new cleanroom operation post-construction.This webinar is ..
Applying Six Sigma "Downtime" in the Bioanalytical Lab
Applies the consideration of the acronym "DOWNTIME" to improve function and efficiency in the LAB. - Defects- reduce or eliminate - Overproduction reduces waste of materials, time, and personnel - Waiting to eliminate waiting on resource access or permission - Non-utilized resources- instruments, personnel - Transportation-movement (temporal or spatial) of resources/or documents&nbs..
Risk Management for Medical Devices per ISO 14971
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stag..
Sampling by Variables (ANSI/ASQ Z1.9, formerly MIL-STD 414)
ANSI/ASQ Z1.9 (formerly MIL-STD 414) is an acceptance sampling plan that uses the average measurement of a sample, and its range or standard deviation, to determine whether a production lot should be accepted. This webinar will show how to select and use sample plans.Attendees will receive a pdf copy of the slides and accompanying notes, and an Excel spreadsheet that converts a traditional sampling plan i..
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior can be managed, reducing the likelihood of these occurrences. When wor..
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s when using SaaS/Cloud
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with the EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, s..
Microbiome: Ideas, Approaches, Regulatory, Integrative Technologies, and Future Directions
The microbiome is a little-understood aspect of human physiology. Microbiomes are found mainly in the gastrointestinal tract. However, simulation of microbiomes is increasingly needed to understand both the flora and fauna of microbial and its synthesis in modern biotechnology process systems.Flora and Fauna identification and speciation are part of this system, using either traditional incubation and..
Unlocking Manufacturing Effectiveness: Practical Strategies for Overcoming Production Constraints
In today’s fast-paced manufacturing environment, being busy doesn’t always translate to being productive. Operations that appear smooth on the surface may in fact be stagnant—or even declining—in terms of output. The hidden culprit is often an overlooked constraint or bottleneck quietly limiting the entire system’s performance.In this session, industry expert José Ignacio Mora shares a practical approach in..
Basics of Clinical Trials
Useful for those entering the pharma industry or academics to understand how clinical trials are conducted. The study objectives, endpoints, entry criteria, study visits, evaluations, safety assessments, statistical considerations, manufacturing and compound supply, and regulatory considerations. The design of randomized, placebo studies can be open-label or blinded (single, double, or triple-blinded). ..
Essentials of Post Market Surveillance and Vigilance - Do you know the requirements?
The post-market phase of a product’s lifecycle is as crucial as its development and pre-market phases. Once a product reaches the market, its real-world performance, safety, and effectiveness must be closely monitored to meet regulatory requirements and ensure patient safety. Post Market Surveillance (PMS) and vigilance programs are essential tools in identifying potential risks, mitigating issues, and driv..